Status:
UNKNOWN
Treatment of Refractory Patellar Tendinopathy With Mesenquimal Trunk Cells. Comparative Study With PRP.
Lead Sponsor:
Institut de Terapia Regenerativa Tissular
Conditions:
Patellar Tendinopathy
Eligibility:
MALE
18-48 years
Phase:
NA
Brief Summary
This is a clinical trial, unicentric, prospective, controlled, randomized, double blind during the experimental phase A. In the experimental phase B, it is contemplated to administer the experimental...
Detailed Description
* Main objective 1. Confirm the presence of patellar tendon gap regeneration after the peritendinous and intratendinous infusion of MSV and compare it with the P-PRP group, evaluated by ECO, NMR an...
Eligibility Criteria
Inclusion
- Male sex with ages between 18 and 48 years.
- Pain in the patellar tendon, located in the patellar insertion area, of more than 4 months of duration that does not show significant improvement after conservative treatments such as rest, analgesia, physiotherapy and / or infiltration.
- Ultrasound image that confirms, both static and dynamic, the loss of the fibrillar structure of the proximal part of the patellar tendon, its thickening and a hypoechoic lesion compatible with gap ≥3mm.
- MRI of the patellar tendon in T2 FAT SAT sequence (fat saturation) that shows a gap ≥3mm in longitudinal diameter in the proximal insertion.
- Informed Consent in writing and signed by the patient.
- The patient is able to understand the nature of the study.
Exclusion
- Patient under 18 years of age (or legally dependent) and over 48 years of age.
- MRI with grade III-IV intra-articular pathology of all compartments of the knee and / or cruciate ligament injury
- Local treatment with corticosteroids during the last year
- Local treatment with PRP during the last 6 months.
- Present infection (no local or systemic infectious signs should be evidenced).
- Patients presenting positive serology in front of:
- HIV 1 and 2, Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ab), Lúes.
- Congenital or evolutive diseases that translate malformation and / or significant deformations of the knee and condition difficulties of application and evaluation of the results.
- Weight overload expressed in body mass index (BMI) greater than 30.5 (obesity grade II). Being BMI = mass (Kg): (height (m)) 2
- Active neoplastic disease.
- Active immunosuppressive states.
- Simultaneous participation in another clinical trial or treatment with another product in the Research phase in the 30 days prior to inclusion in the study.
- Other pathologies or circumstances that compromise participation in the study according to medical criteri
Key Trial Info
Start Date :
December 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03454737
Start Date
December 13 2017
End Date
December 14 2020
Last Update
December 19 2018
Active Locations (1)
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1
Institut de Terapia Regenerativa Tissular
Barcelona, Spain, 08022